CTMS

DDOTS is a research management software platform designed for clinical research sites and institutions. It covers the full scope of research operations across five core areas: clinical trial management (CTMS), investigational pharmacy, biorepository, IRB submissions, and eRegulatory document management. All modules operate under a single login and share a unified platform, allowing data entered in one module to be used across others.

DDOTS has been developing research software for nearly 30 years. The platform is cloud-hosted, accessible remotely, and supports integration with external systems including EHR via HL7, single sign-on, and a public API. It is designed to be configurable, with options to customize system behavior and data management across each module.

CTMS Capabilities

• Site activation and protocol data management
• Schedule of events and budget management
• Key personnel activity tracking
• Integrated eRegulatory document management
• Monitor activities and monitor access controls
• Participant recruitment, enrollment, and tracking
• Visit calendars
• Deviation and adverse event (AE) tracking
• Re-consenting workflows
• Invoicing, payment tracking, and accounts receivable allocation
• Billing compliance tools and coverage analysis
• Comprehensive reporting across protocols, participants, financials, and regulatory data

Pharmacy Module Capabilities

• When used with DDOTS CTMS, draws from the same protocol record and schedule of events to populate provided agents and create dispense schedules for participants
• Tracks agent receipt, dispensing, return, and destruction
• Generates customizable drug accountability records (DARFs) to meet sponsor requirements
• Inventory management with notifications for expiring agents
• Manages transports between pharmacies, automates drug accountability records at each location, and captures transport verification prior to dispensing
• Custom label printing
• Electronic document management with Part 11-compliant electronic signatures
• Monitor activity logging and electronic verification
• Financial capabilities including event capture, invoicing, and payment tracking
• Participant dispense visit calendars and comprehensive reporting

Biorepository Module Capabilities

• Manages and stores biological samples such as tissue and blood with detailed specimen information
• Tracks sample location by freezer, shelf, and rack
• Links samples to protocols and participants with study dates and consent records
• Creates participant collection schedules based on protocol schema
• Generates specimen barcode and QR code labels
• Tracks transfers to external researchers for chain of custody management
• Generates manifests and packing slips for print, email, or PDF
• Financial capabilities with invoice generation and payment tracking
• Comprehensive reporting

IRB Module Capabilities

• When used with DDOTS CTMS, uses the same protocol record to enter submissions and track review history
• Notifications and review status tracking
• Document management with Part 11-compliant electronic signature capability
• Assigns submissions to reviewers with email notifications
• Electronic submission review and commenting with automatic notification upon review completion
• Manages multiple IRBs or committees with separate meeting schedules and agendas
• Manages IRB membership rosters, voting rights, and recusals
• Dynamically creates agendas based on submissions entered
• Automated approval letters
• Financial capabilities with invoice generation and payment tracking
• Comprehensive reporting

Integrated eRegulatory

• All DDOTS modules include integrated eRegulatory functionality, eliminating the need for a separate document management system
• Stores trial-related documents — including protocols, investigator brochures, consent forms, monitoring reports, and regulatory submissions — in a centralized, access-controlled location
• Supports Part 11-compliant electronic signatures for requesting, tracking, and signing documents electronically

Platform and Integration Features

• Single login across all modules
• EHR integration via HL7
• API support for integration with accounting, marketing, and other departmental systems
• Single sign-on (SSO) support
• Over 100 out-of-the-box reports covering protocols, participants, regulatory, and financials; custom reports available on request
• Extensive system configuration options for customizing behavior and data management

Availability, Security, and Support

• Cloud-hosted with data accessible from any location to support business continuity
• Proactive monitoring and maintenance to prevent issues and optimize performance
• Regular updates including security patches and feature enhancements
• Data retention and recovery capabilities
• Support provided via direct contact with a person or through online tools, with an issue capture system for proactive problem identification